Mark McCarty

The U.K. National Institute for Health and Care Excellence has offered a thumbs-up for eight digital technologies to help patients with asthma manage their conditions. The sponsors of these products have three years to turn out enough evidence to persuade NICE to fully endorse those products, after which these platforms could have access to a market of more than five million patients.

The U.S. FDA’s reissuance of the 2019 guidance for general wellness products seems to carve out new territory for makers of wearables that make modest claims regarding health, but anyone who was expecting a clear break with the 2019 version of the guidance was almost certainly disappointed.

Generative AI has largely escaped the U.S. FDA’s regulatory purview up to now, but OpenAI seems poised to create a new source of regulatory angst for the agency. The company unveiled its ChatGPT Health Jan. 7, a large language model that when used professionally could land the company in the FDA’s regulatory crosshairs.

The FDA's device center issued an April 16 notice on device-led combination products that may contain harmful levels of nitrosamines, such as the antimicrobial rifampin.

The Centers for Medicare & Medicaid Services announced another push in the effort to reduce the time needed to obtain prior authorization (PA) from payers. The agency seems poised to apply significant pressure on payers across the board, and lab tests could be next.

Abbott Vascular recently came away with a victory in a California lawsuit concerning HeartMate 3 ventricular assist device, which was still an investigational device at the time of implant. However, at least one attorney believes that the concept of duty-to-innovate could feature in future cases.

CMS has proposed expanding TAVR coverage to include patients with asymptomatic severe aortic stenosis, which analysts called a clear win for Edwards Lifesciences. The draft NCD stops short of addressing TAVR treatment for pure aortic regurgitation.

With the FDA's one-day inspection pilot ending Sept. 30, key questions remain unanswered: how sites are selected, what AI is feeding the risk algorithm, and what findings could trigger a full inspection. Regulatory counsel urges device makers to prepare as for any audit.

CMS's draft 2027 physician fee schedule would bar contractors from billing for remote patient monitoring — a direct threat to device companies that built managed-service RPM businesses. OIG fraud findings appear to be driving the change.

CMS has now signaled in both the FY 2027 inpatient and CY 2027 outpatient drafts that the alternative pass-through program for breakthrough devices may be restructured — a warning that could affect eligibility for devices already in the payment queue.